BEUDAMED
    FDA Enforcement Class II Ongoing

    Wuxi Nest, model numbers 202115, 202117, 202017, 202018 - Product Usage: Patient specimen collection.

    Recall: Z-0449-2021 · Reported November 25, 2020

    Enforcement

    Recall Number
    Z-0449-2021
    Event ID
    86607
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Thomas Scientific
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 25, 2020
    Initiation Date
    July 14, 2020
    Classification Date
    November 13, 2020
    Address
    1654 High Hill Rd, N/A, Swedesboro, NJ, 08085-1780, United States

    Description

    Wuxi Nest, model numbers 202115, 202117, 202017, 202018 - Product Usage: Patient specimen collection.

    Reason

    The firm is replacing all tubes that were manufactured and distributed prior to Enforcement Discretion Approval.

    Code Info

    Lots 060620MB1 061420MB2 062120MB1 062220MB2 060620MB2 052220MB1 051820D01 060120D01 061520MA1 062220D02 061720MB1 052720D02 061920E01 052120E01

    Distribution

    US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KA, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.

    Quantity

    115,800 cs (100 vials/cs)